AADvac1 for Progressive Supranuclear Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AADvac1, a potential vaccine for Progressive Supranuclear Palsy (PSP), a brain disorder affecting movement and balance. The trial aims to assess the safety and effectiveness of AADvac1 in managing PSP symptoms. Suitable participants have experienced PSP symptoms for 5 years or less and can walk at least 10 steps with minimal assistance. Participants will receive either AADvac1 or a placebo (a substance with no active drug) to compare outcomes. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that AADvac1 is likely to be safe for humans?
A previous study tested AADvac1 in humans to assess its safety. Participants generally tolerated AADvac1 well. Some experienced side effects, mostly mild, such as headaches or soreness at the injection site. Serious side effects were rare.
Since this trial is in an early phase, some evidence suggests that AADvac1 is safe, but further research is necessary to confirm this. The trial aims to gather more information on the safety of AADvac1 for people with progressive supranuclear palsy (PSP). Participants will be closely monitored for any side effects.12345Why do researchers think this study treatment might be promising for PSP?
Unlike the standard treatments for progressive supranuclear palsy, which primarily focus on managing symptoms, AADvac1 targets the disease's underlying causes. AADvac1 is a vaccine that aims to prevent the accumulation of abnormal tau proteins in the brain, a hallmark of this condition. Researchers are excited about this treatment because it offers a potential disease-modifying approach rather than just symptomatic relief, which could slow or halt the progression of the disease.
What evidence suggests that AADvac1 might be an effective treatment for PSP?
Research has shown that AADvac1, which participants in this trial may receive, is being tested as a potential treatment for Progressive Supranuclear Palsy (PSP). Early results suggest that AADvac1 might slow the progression of PSP. This is significant because no effective treatments currently exist for this condition. AADvac1 targets tau proteins, believed to be involved in PSP. Although more research is necessary, initial studies indicate it could be promising in managing this challenging disease.678910
Who Is on the Research Team?
Irene Litvan, MD
Principal Investigator
University of California, San Diego
Julio Rojas-Martinez, MD, PhD
Principal Investigator
University of California, San Francisco
Anne-Marie Wills, MD
Principal Investigator
Massachusetts General Hospital
Adam Boxer, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people diagnosed with possible or probable Progressive Supranuclear Palsy (PSP) Richardson's Syndrome, who have had symptoms for 5 years or less. Participants must be able to walk at least 10 steps with minimal help, have good mental function, and live at home or in the community.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a baseline assessment before randomization
Treatment
Participants receive either AADvac1 or matching placebo for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AADvac1
Trial Overview
The study is testing AADvac1, an experimental drug, compared to a placebo in people with PSP. The goal is to see if AADvac1 is safe and effective. Participants are randomly assigned to receive either the drug or a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adam Boxer
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Alzheimer's Therapeutic Research Institute
Collaborator
University of Southern California
Collaborator
Massachusetts General Hospital
Collaborator
Alzheimer's Clinical Trials Consortium
Collaborator
University of California, San Diego
Collaborator
Axon Neuroscience SE
Industry Sponsor
Citations
Predicting Disease Progression in Progressive Supranuclear ...
There are no effective therapies for PSP; predict attrition or disease progression over one year. had a slower rate of progression.
Axon Neuroscience's Immunotherapy Selected for a ...
The Phase 2 trial aims to assess the safety and efficacy of AADvac1 both as a monotherapy and in combination with an approved anti-amyloid ...
UCLA Progressive Supranuclear Palsy
This study includes subjects with Progressive Supranuclear Palsy (PSP). Subjects were enrolled in the davenutide PSP Phase Trail 2/3.
4.
researchgate.net
researchgate.net/publication/341637336_Progressive_supranuclear_palsy_Advances_in_diagnosis_and_managementProgressive supranuclear palsy: Advances in diagnosis ...
Results Data were analyzed from 323 infants and children, including 240 treated with nusinersen (100 with infantile-onset SMA and 140 with later-onset SMA) ...
5.
natlawreview.com
natlawreview.com/press-releases/axon-neurosciences-immunotherapy-selected-landmark-combination-therapyAxon Neuroscience's Immunotherapy Selected for a ...
The Phase 2 trial aims to assess the safety and efficacy of AADvac1 both as a monotherapy and in combination with an approved anti-amyloid ...
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